RecruitingNot ApplicableNCT06684392

Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Tracheostomized Subjects

Assessment of the Effect of an Inspiratory Muscle Training Regimen on Decannulation Time in Adult Hospitalized Subjects with Tracheostomy Secondary to Prolonged Mechanical Ventilation


Sponsor

Hospital Dr. Franco Ravera Zunino

Enrollment

56 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this project is to evaluate the effect of applying an individualized inspiratory muscle training regimen, combining strength and endurance exercises over a two-week period, on improving maximum inspiratory pressure, diaphragm thickness fraction, and its impact on successful decannulation time in patients with tracheostomy secondary to prolonged mechanical ventilation at HRLBO. Two groups of adult tracheostomized patients will be assessed: an experimental group, who will follow an individualized inspiratory muscle training regimen for 14 days along with standard physiotherapy, and a control group, who will receive standard physiotherapy and guided weaning through scheduled disconnection windows from mechanical ventilation. Both groups will be compared in terms of decannulation time, ICU length of stay, hospital days, and quality of life survey scores. The results of this study will help optimize the management of tracheostomized patients locally and nationally, reducing economic costs for both the country and the patients, and improving their quality of life, contributing to some health objectives for the 2011-2020 decade.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Critically ill patients aged ≥ 18 years
  • Connected to mechanical ventilation
  • Secondary tracheostomy due to prolonged mechanical ventilation
  • Glasgow Coma Scale (GCS) \> 11 points
  • Level of cooperation score (S5Q) \> 3 points

Exclusion Criteria5

  • Limitation of therapeutic effort (LTE\*)
  • Pregnancy
  • Transfer to another center before completing the training (2 weeks)
  • Degenerative neuromuscular disease
  • Refusal to participate in this study (declining to provide informed consent \[IC\]).

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Interventions

OTHERInspiratory muscle training

Subjects will train only inspiratory muscle strength if they do not achieve VP or definitive disconnection of MV, and, when they already achieve these VP or definitive disconnection, the new EMI regimen that combines strength and resistance training will begin to be applied. Inspiratory muscle training guideline (EMI). On the day that, according to the EMI guideline, the Pimax evaluation corresponds, the training time will be replaced by the evaluation to avoid overloading the subjects with ventilatory work, training them only once a day.


Locations(1)

Hospital Regional Franco Ravera Zunino

Rancagua, Región del Libertador General Bernardo O’Higgins, Chile

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NCT06684392


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